FDA Adverse Event
Injury
Summary report: N
R3
MDR report key: 2132893
·
Received June 17, 2011
Report
- Report Number
- 1020279-2011-00202
- Event Type
- Injury
- Date Received
- June 17, 2011
- Date of Event
- April 7, 2011
- Report Date
- June 17, 2011
- Manufacturer
- SMITH AND NEPHEW, INC.
- Product Code
- JDG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THE PRODUCT INITIALLY REPORTED WAS NOT A SMITH AND NEPHEW PRODUCT.
Description of Event or Problem · 1
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | R3 | ACETABULAR CUP | JDG | SMITH AND NEPHEW, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Hospitalization |